title: Off-label medicine use in children and adolescents: results of a population-based study in Germany.
abstract: BACKGROUND
  Population-based self-reported data on off-label medicine use independent from health care provisions are lacking. The purpose of this study is to investigate off-label medicine use in children and adolescents in Germany in a non-clinical setting and to identify prevalence, determinants and spectrum of off-label medicine use.
  
  
  METHODS
  Data were obtained from the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) conducted by the Robert Koch Institute (2003-2006). 17,450 randomly selected children aged 0-17 years took part in the drug interviews. Of those, 8,899 took at least one medicine during the 7 days preceding the interview. Off-label medicine use was defined as the discrepancy between actual use and the intended use described in the summary of product characteristics. Off-label medicine use was stratified into off-label indication, off-label age, off-label over-dosing, and off-label under-dosing.
  
  
  RESULTS
  The prevalence rate of off-label medicine use among those who used medicines amount of is 40.2%. The prevalence rate is significantly higher in boys (41.4%), in children aged 3 to 6 years (48.7%), without migration background (40.9%), with high social status (42.5%), living in small (42.0%) and medium sized cities (41.6%), and with a poor parents rated health status (41.7%). 12,667 preparations (attributable in respect to off-label use) were taken by 8,899 children. 30% of the medicines have been used off-label. Off-label medicine use was highest in preparations of the ATC-class "C00 Cardiovascular System". In all origins of medicine, all age groups and all ATC-classes under-dosing was the most frequent reason for off-label medicine use.
  
  
  CONCLUSIONS
  There is a considerable level of self-reported off-label medicines use in the general paediatric population. Further investigations are needed to examine in how far off-label medicine use is based on lack of knowledge or on empiricism in paediatric pharmacotherapy. Attention also needs to be paid to under-dosing which potentially exposes drug users to risks of side effects without the benefit of a therapeutic effect. Clinical trials for licensing of paediatric medicines, education of health care professionals, but also of parents and carers are needed to ensure the rational use of medicines.
authors.affiliation: Department of Epidemiology and Health Monitoring, Robert Koch Institute, General-Pape-Str, 62-66, 12101, Berlin, Germany. knopfh@rki.de.
authors.forename: Hildtraud
authors.initials: H
authors.lastname: Knopf
authors.forename: Ingrid-Katharina
authors.initials: IK
authors.lastname: Wolf
authors.forename: Giselle
authors.initials: G
authors.lastname: Sarganas
authors.forename: Wanli
authors.initials: W
authors.lastname: Zhuang
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rascher
authors.forename: Antje
authors.initials: A
authors.lastname: Neubert
mesh_terms: D000293:Adolescent; D016497:Adolescent Health Services; D002648:Child; D002669:Child Welfare; D002675:Child, Preschool; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D004366:Nonprescription Drugs; D056687:Off-Label Use; D015995:Prevalence; D012651:Self Medication
chemical_list: D004366:Nonprescription Drugs